BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4932557 · Received July 22, 2015

    Report

    Report Number
    2531779-2015-24958
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 5, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 9/10/15 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS EVIDENCE OF POWER ON RESET. PUMP RETURNED WITH VISIBLE MOISTURE IN THE DISPLAY LENS. NO DAMAGE FOUND TO RETURNED BATTERY CAP OR THE BATTERY COMPARTMENT. RETURNED BATTERY CAP FITS SECURELY TO THE PUMP. PUMP HAS AUDIBLE BUT NO VIBRATORY FEATURES; THE DISPLAY SCREEN REMAINS BLANK. DAMAGE TO THE PUMP CASE WAS OBSERVED NEAR THE UPPER RIGHT CORNER BETWEEN THE DISPLAY LENS AND THE COVER. PUMP FAILS IN-HOUSE LEAK TEST DUE TO DAMAGE TO PUMP CASE. THE PUMP COVER WAS REMOVED; INTERNAL MOISTURE WAS PRESENT IN PUMP. UNABLE TO COMPLETE REQUIRED ALL INVESTIGATION STEPS DUE TO INTERNAL MOISTURE DAMAGE IN THE PUMP. RETURNED BATTERY CAP/RETURNED CARTRIDGE CAP USED FOR TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477686 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR